Closed-loop Synchronization Versus Conventional Synchronization

NCT ID: NCT05731024

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2025-12-30

Brief Summary

A prior research indicated that asynchrony between the patient and ventilator occurred in 33 percent of 19,175 breaths, and was seen in every patient. The most prevalent kind of asynchrony was ineffective triggering (68%), followed by delayed termination (19%), double triggering (4%) and premature termination (3%). Asynchrony between the patient and ventilator increased considerably with decreasing levels of peak inspiratory pressure, positive end-expiratory pressure, and set frequency.Despite this, more asynchrony categories exist, and there is no widely accepted categorization. Major asynchronies, however, include auto trigger, ineffective effort, and double trigger, while minor asynchronies include early/late cycle, trigger delay, and spontaneous breaths during a mandatory breath. This study aims to compare the safety and efficacy of a closed-loop synchronization controller with conventional control of synchronization during invasive mechanical ventilation of spontaneous breathing of pediatric patients in a pediatric intensive care unit (PICU).

Conditions

Acute Respiratory Failure; Pediatric Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Close-loop synchronization controller

One-hour period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during SPONT mode.

Group Type: EXPERIMENTAL

close-loop synchronization controller with SPONT mode

Intervention Type: DEVICE

One-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient.

Conventional

One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set.

Group Type: ACTIVE_COMPARATOR

Conventional synchronization settings with SPONT mode

Intervention Type: DEVICE

One-hour period where the pressure support of spontaneous breath will be manually set.

Interventions

close-loop synchronization controller with SPONT mode

One-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient.

Intervention Type: DEVICE

Conventional synchronization settings with SPONT mode

One-hour period where the pressure support of spontaneous breath will be manually set.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pediatric patients older than 1 month and younger than18 years of age
• Hospitalized at the PICU with the intention of treatment with mechanical ventilation at least for the upcoming 3 hours with spontaneous breathing activity
• Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation

Exclusion Criteria

• Formalized ethical decision to withhold or withdraw life support
• Patient included in another interventional research study under consent
• Patient already enrolled in the present study in a previous episode of respiratory failure
• Pregnant woman
• Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital
• Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
• Not being able to obtain reference waveform

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Medical AG

INDUSTRY

Sponsor Role: collaborator

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hasan ağın

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Agin, Professor

Role: PRINCIPAL_INVESTIGATOR

Behcet Uz Children's Hospital

Locations

Aydin Obstetric and pediatrics Hospital

Aydin, , Turkey (Türkiye)

Site Status: RECRUITING

Erzurum Regional Research and Training Hospital

Erzurum, , Turkey (Türkiye)

Site Status: RECRUITING

Erzurum Regional Research and Training Hospital

Erzurum, , Turkey (Türkiye)

Site Status: RECRUITING

Cam Sakura Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hasan Agin, Professor

Role: CONTACT

hasanagin@gmail.com

+905362013162

Facility Contacts

ekin soydan

Role: primary

dr-ekinsoydan@hotmail.com

+905321003949

Pinar Hepduman, MD

Role: primary

pnrhpdmn@gmail.com

+905531501115

Sevgi Topal, MD

Role: primary

+905078645922

Mustafa Colak, MD

Role: primary

colakk@hotmail.com

+905554180903

Ozlem Sandal, MD

Role: primary

drozlemsarac@hotmail.com

+905067644688

Gulhan Atakul, MD

Role: backup

gulhanatakul@gmail.com

References

van Dijk J, Blokpoel RGT, Abu-Sultaneh S, Newth CJL, Khemani RG, Kneyber MCJ. Clinical Challenges in Pediatric Ventilation Liberation: A Meta-Narrative Review. Pediatr Crit Care Med. 2022 Dec 1;23(12):999-1008. doi: 10.1097/PCC.0000000000003025. Epub 2022 Jul 14.

Reference Type: BACKGROUND

PMID: 35830707 (View on PubMed)

Emeriaud G, Newth CJ; Pediatric Acute Lung Injury Consensus Conference Group. Monitoring of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5 Suppl 1):S86-101. doi: 10.1097/PCC.0000000000000436.

Reference Type: BACKGROUND

PMID: 26035368 (View on PubMed)

Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.

Reference Type: BACKGROUND

PMID: 26914624 (View on PubMed)

Colleti J Jr, Brunow de Carvalho W. Patient-Ventilator Asynchrony During Assisted Ventilation in Children: The Time to Rethink Our Knowledge. Pediatr Crit Care Med. 2016 Aug;17(8):811. doi: 10.1097/PCC.0000000000000793. No abstract available.

Reference Type: BACKGROUND

PMID: 27500623 (View on PubMed)

Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Jaecklin T, Levy-Jamet Y, Tourneux P, Jolliet P, Rimensberger PC. Optimizing patient-ventilator synchrony during invasive ventilator assist in children and infants remains a difficult task*. Pediatr Crit Care Med. 2013 Sep;14(7):e316-25. doi: 10.1097/PCC.0b013e31828a8606.

Reference Type: BACKGROUND

PMID: 23842584 (View on PubMed)

Blokpoel RGT, Burgerhof JGM, Markhorst DG, Kneyber MCJ. Trends in Pediatric Patient-Ventilator Asynchrony During Invasive Mechanical Ventilation. Pediatr Crit Care Med. 2021 Nov 1;22(11):993-997. doi: 10.1097/PCC.0000000000002788.

Reference Type: BACKGROUND

PMID: 34054119 (View on PubMed)

Other Identifiers

02019336

Identifier Type: -

Identifier Source: org_study_id